Council Minutes Feb 2012 Final

Meeting Minutes

Department of Health and Human Services

National Institutes of Health

National Institute of Diabetes and Digestive and Kidney Diseases

February 15, 2012

I. CALL TO ORDER

Dr. Rodgers

Dr. Griffin P. Rodgers, Director, NIDDK, called to order the 188th meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council at 8:30 a.m., Wednesday, February 15, 2012, in the Natcher Conference Center (Building 45), Conference Rooms E1/E2, on the NIH campus in Bethesda, Maryland.

A.  ATTENDANCE – COUNCIL MEMBERS PRESENT

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Dr. Domenico Accili

Ms. LaVarne Burton

Dr. Judy H. Cho

Dr. Robert C. Flanigan

Dr. Christopher K. Glass

Dr. Gregory J. Gores

Ms. Jane Holt

Ms. Judy M. Hunt

Dr. Thomas R. Insel

Dr. Francine R. Kaufman

Dr. Kenneth Kaushansky

Dr. David M. Klurfeld

Ms. Robin Nwankwo

Dr. Jerry P. Palmer

Dr. Thomas N. Robinson

Dr. Anil K. Rustgi

Dr. John R. Sedor

Dr. Alan R. Shuldiner

Dr. William D Steers

Dr. Robert A. Vigersky

Mr. John W. Walsh

Dr. Mark L. Zeidel

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Also Present:

Dr. Griffin Rodgers, Director, NIDDK, and Chairperson, NIDDK Advisory Council

Dr. Gregory Germino, Deputy Director, NIDDK

Dr. Brent Stanfield, Executive Secretary, NIDDK Advisory Council

B.  NIDDK STAFF AND GUESTS

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Abankwah, Dora – NIDDK

Abraham, Kristin – NIDDK

Agodoa, Lawrence – NIDDK

Akolkar, Beena – NIDDK

Appel, Michael – NIDDK

Arreaza-Rubin, Guillermo – NIDDK

Atkins, Ronald – CSR

Barnard, Michele – NIDDK

Begum, Najma – NIDDK

Bishop, Terry – NIDDK

Bleasdale, John – CSR

Blondel, Olivier – NIDDK

Josephine Briggs – NCATS

Broitman, Marina – NCATS

Brown, Sherry – NIDDK

Camp, Dianne – CSR

Carrington, Jill – NIDDK

Castle, Arthur – NIDDK

Chen, Hui – CSR

Chen, Richard – NIDDK

Christenson, Dane – Pulm. Hyperten. Assoc.

Cleffi, Katie – RTI International

Connaughton, John – NIDDK

Copeland, Randy – NIDDK

Cowie, Catherine – NIDDK

Curtis, Leslie – NIDDK

Dayal, Sandeep – NIDDK

Doherty, Dee – NIDDK

Donohue, Patrick – NIDDK

Doo, Edward – NIDDK

Drew, Devon – NIDDK

Eggerman, Thomas – NIDDK

Eggers, Paul – NIDDK

Ehrhardt, Britt – NIDDK

Evans, Mary – NIDDK

Everhart, James – NIDDK

Fallon, Erica – NIDDK

Farishian, Richard – NIDDK

Feld, Carol – NIDDK

Flessner, Mike – NIDDK

Fonville, Olaf – NIDDK

Fradkin, Judith – NIDDK

Gansheroff, Lisa – NIDDK

Goter-Robinson, Carol – NIDDK

Giambarresi, Leo – AUA

Graves, Reed – CSR

Grey, Michael – NIDDK

Guo, Xiaodu – NIDDK

Haft, Carol – NIDDK

Hamilton, Frank – NIDDK

Hanlon, Mary – NIDDK

Hardy, Dianne – CSR

Hayward, Anthony – NCATS

Hoff, Eleanor – NIDDK

Horlick, Mary – NIDDK

Hoshizaki, Deborah – NIDDK

Hubbard, Van – NIDDK

Kathy Hudson – NCATS

Hunter, Helen – NIDDK

Hyde, James – NIDDK

James, Stephen – NIDDK

Jenkins, Connie – NIDDK

Jones, Teresa – NIDDK

Karp, Robert – NIDDK

Karimbakas, Joanne – NIDDK

Ketchum, Christian – NIDDK

Khan, Mushtaq – CSR

Kim, Sooja – CSR

Kimmel, Paul – NIDDK

Kirkali, Ziya – NIDDK

Kranzfelder, Kathy – NIDDK

Kuczmarski, Robert – NIDDK

Kusek, John – NIDDK

Laughlin, Maren – NIDDK

Lescheck, Ellen – NIDDK

Linder, Barbara – NIDDK

Malik, Karl – NIDDK

Malozowski, Saul – NIDDK

Maruvada, Padma – NIDDK

Margolis, Ronald – NIDDK

Martey, Louis – NIDDK

Mowery, Penny – NIDDK

McBryde, Kevin – NIDDK

McKeon, Catherine – NIDDK

Miller, David – NIDDK

Miller, Megan – NIDDK

Moxey-Mims, Marva – NIDDK

Mullins, Chris – NIDDK

Narva, Andrew – NIDDK

Nelson, Barbara – NCATS

Newman, Eileen – NIDDK

Panniers, Richard – CSR

Pawlyk, Aaron – NIDDK

Pellnitz, Lori – SRI Inter.

Perry-Jones, Aretina – NIDDK

Pike, Robert – NIDDK

Podskalny, Judith – NIDDK

Polglase, Williams – NIDDK

Portnoy, Matt – OER

Rasooly, Rebekah – NIDDK

Reiter, Amy – NIDDK

Ripley, Justin – PWC

Roberts, Tibor – NIDDK

Rys-Sikora, Krystyna – NIDDK

Salaita, Christine –NIDDK

Salomon, Karen – NIDDK

Sahai, Atul – CSR

Sankaran, Lakshmanan – NIDDK

Sanovich, Elena – NIDDK

Sato, Sheryl – NIDDK

Savage, Peter – NIDDK

Serrano, Jose – NIDDK

Sherker, Averell – NIDDK

Shepherd, Aliecia – NIDDK

Silva, Corrine – NIDDK

Smith, Philip – NIDDK

Sheard, Nancy – CSR

Spain, Lisa – NIDDK

Star, Robert – NIDDK

Staten, Myrlene – NIDDK

Steinberg, Jane – NCATS

Tatham, Thomas – NIDDK

Tuncer, Diane – NIDDK

Van Raaphorst, Rebekah – NIDDK

Viswanathan, Mohan – NCATS

Wallace, Julie – NIDDK

Naus, Wendy – Lewis-Burke

Wellner, Robert – NIDDK

Wright, Daniel – NIDDK

Wright, Elizabeth – NIDDK

Yanovski, Susan – NIDDK

Zhang, Guo – NCATS

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C. ANNOUNCEMENTS

Dr. Rodgers made the following announcements:

New Council Members

Dr. Rodgers welcomed four new members to the NIDDK National Advisory Council and expressed his gratitude, on behalf of the NIDDK, for their willingness to take time from their busy schedules to advise the Institute.

Joining the Diabetes, Endocrinology and Metabolic Diseases (DEM) Subcouncil are Drs. Alan Shuldiner and Robert Vigersky.

Dr. Alan Shuldiner is the John Whitehurst Professor of Medicine, Associate Dean for Personalized Medicine, Director of the Program in Personalized Medicine, and Head of the Division of Endocrinology, Diabetes and Nutrition at the University of Maryland School of Medicine. He is a very productive researcher whose major research interests are the molecular basis and genetics of type 2 diabetes, obesity, and insulin resistance. His research is supported by the NIH, the American Diabetes Association and the Juvenile Diabetes Foundation. The NIDDK has supported his research since 1996. Since 1999, he has served on nearly 50 peer review panels as either a standing Study Section member or as an ad hoc reviewer. Dr. Shuldiner earned his M.D. from Harvard Medical School. He then completed his residency in Medicine at Columbia-Presbyterian Hospital in New York and a Fellowship in Endocrinology within the Diabetes Branch at the NIDDK.

Dr. Robert Vigersky is a Colonel in the Medical Corps at Walter Reed Army Medical Center, and Medical Director of the Diabetes Institute of the Walter Reed Health Care System. He is also a Professor within the Department of Medicine of the Uniformed Services University of the Health Sciences. He is serving as the Department of Defense Ex Officio member on the Council. Dr. Vigersky has had a very distinguished academic and medical career as an endocrinologist working at the NIH, within the military, and in private practice. Over the course of his career, he has published extensively in the peer-reviewed literature on topics ranging from reproductive endocrinology, to diabetes management, to telemedicine and e-health. Dr. Vigersky served as President of the Endocrine Society from 2009 to 2010. He earned his M.D. at Boston University and then did his internship and residency work at the Johns Hopkins Hospital.

Joining the Digestive Diseases and Nutrition (DDN) Subcouncil is Mr. John W. Walsh.

Mr. John W. Walsh will serve as a public member of the Council. After being diagnosed with Alpha-1 Antitrypsin Deficiency (Alpha-1) in 1989, Mr. Walsh co-founded the Alpha-1 Foundation, a not-for-profit corporation dedicated to providing the leadership and resources to increase research, improve health, promote worldwide detection, and find a cure for Alpha-1. Mr. Walsh has an extensive background in business management and government relations. He has served three terms on the Department of Health and Human Service’s Advisory Committee on Blood Safety and Availability (1997-2006); is Immediate-Past Chairperson of the National Health Council’s Board of Directors (2005-2006); Past Chair and a member of the American Thoracic Society Public Advisory Roundtable; and a Presidential Appointee of the American Thoracic Society’s Board of Directors (2004-2005). Mr. Walsh regularly testifies before Congress and advisory groups as a patient advocate. In 2002, Mr. Walsh’s contribution to pioneering collaboration in orphan drug development was recognized by the FDA with the Commissioner’s Special Citation. In 2006, he was awarded the prestigious Claude Pepper Memorial Award for Healthcare for his outstanding achievements and contributions to the healthcare industry.

Joining the Kidney, Urologic and Hematologic Diseases (KUH) Subcouncil is Dr. Kenneth Kaushansky.

Dr. Kenneth Kaushansky is Dean of the School of Medicine and Senior Vice President of the Health Sciences for Stony Brook University. Prior to assuming that position in 2012, he served as the Helen M. Ranney Professor and Chair of the Department of Medicine at the University of California, San Diego. From 1987 to 1995, he held a series of positions at the University of Washington--Assistant Professor, Associate Professor, and Professor, and he also served as Hematology Section Chief at the University of Washington Medical Center. A member of the Institute of Medicine, Dr. Kaushansky is a leader in hematology research. He has conducted seminal research on the molecular biology of blood cell production. His team cloned several of the genes important in the growth and differentiation of blood cells, including thrombopoietin, a key regulator of stem cell and platelet production. He is also an accomplished clinician, who has championed the need to train more physician-scientists to bridge the gap between the laboratory and the clinical arena. Dr. Kaushansky earned his M.D. from the University of California, Los Angeles, and completed his Internal Medicine Internship, Residency, Chief Medical Residency, and Fellowship in Hematology at the University of Washington.

Dr. Rodgers also announced that the appointment of Dr. Thomas Insel as a temporary ex officio Council member.

Dr. Thomas Insel is Director, National Institute of Mental Health, and Acting Director of the new National Center for Advancing Translational Sciences (NCATS) at the NIH. His appointment as a temporary ex officio Council member results from a request by the NIH leadership that the NIDDK’s Council temporarily assume the second-tier peer review responsibilities for research funded by the NCATS until the Center’s own Council is formed. The NCATS was created in statute by the consolidated appropriations law that is funding the Department of Health and Human Services for the remainder of Fiscal Year 2012. The first set of research applications to be considered for funding by the NCATS was transferred to the NIDDK Council for review following the disbanding of the National Center for Research Resources (NCRR), to which they were initially submitted. Dr. Rodgers indicated that these applications would be reviewed in a special Executive Session of the NIDDK Council.

“In Memoriam”

Dr. Wylie Vale, a long-term NIDDK grantee, passed away in early January 2012. He was a Salk Institute professor and a global authority on peptide hormones and growth factors that provide communication between the brain, endocrine, and immune systems. Dr. Vale and his colleagues characterized the peptide known as corticotropin releasing factor (CRF). They demonstrated that the CRF production by certain brain cells triggered many of the body's hormonal, immune and behavioral responses to stressful situations. Dr. Vale's work revealed that an unusual high production of CRF is associated with several disorders; propelled new methods for the diagnosis of pituitary disease; and opened new possibilities for drug development. Dr. Vale was a member of the Institute of Medicine, and the American Academy of Arts and Sciences. He also served as a president of the American Endocrine Society and the International Society of Endocrinology.

NIDDK Staff Changes

Dr. Rodgers welcomed Ms. Camille Hoover as a new NIDDK staff member, and also reported the retirement of Dr. Patricia Robuck.

Ms. Camille Hoover is the NIDDK’s new Executive Officer. Ms. Hoover served as Executive Officer of the National Center for Complementary and Alternative Medicine (NCCAM) since 2000. While there, she played a critical role in the creation and organization of the NCCAM. Earlier in her career, she also served at the NIH Clinical Center and within the NCI's Intramural Research Program. Ms. Hoover has extensive experience in addressing administrative management issues, and is a recognized leader in the NIH corporate community, where she has chaired many trans-NIH committees and workshops.

Dr. Patricia Robuck retired in December 2011 from her position as Senior Advisor for Clinical Trials in Digestive and Liver Diseases within the Division of Digestive Diseases and Nutrition. Dr. Robuck spent 11 of her 27 years of federal civil service with the NIDDK, where she managed a portfolio that included significant involvement with fourteen large multi-center clinical consortia. She was instrumental in the leadership of the Institute’s Clinical Studies Working Group and was an important NIDDK liaison with the FDA. The NIDDK benefited greatly from her expertise regarding the protection of human subjects in research, as well as her skill in the design and implementation of clinical research and trials.

New Publication

NIDDK's Recent Advances and Emerging Opportunities provides examples of NIDDK-supported research advances published in Fiscal Year 2011, longer-term stories of discovery, profiles of patients, and scientific presentations made at Council meetings. Dr. Rodgers acknowledged the NIDDK’s Office of Scientific Program and Policy Analysis for developing the document, and the extramural and intramural scientific staff for their input. The document is posted on the NIDDK website.

http://www2.niddk.nih.gov/AboutNIDDK/ResearchAndPlanning/Advances/FY2012/default.htm

II. CONSIDERATION OF SUMMARY MINUTES OF THE 187th COUNCIL MEETING

Dr. Rodgers

Following a motion that was made and seconded, the Council approved, by voice vote, the Summary Minutes of the 187th Council meeting that had been sent to them earlier for review.

III. FUTURE COUNCIL DATES

Dr. Rodgers

Dr. Rodgers reminded the Council of future meeting dates.

2012

May 16-17 (Wednesday and Thursday)

September 12-13 (Wednesday and Thursday)

Natcher, Conference Rooms E1/E2, D and F1/F2

2013

February 13-14 (Wednesday and Thursday)

May 15-16 (Wednesday and Thursday)

September 26-27 (Thursday and Friday)*

Building 31, Conference Rooms 10, 6 and 7

* Note divergence from familiar Wednesday and Thursday schedule

The NIDDK expects that most meetings will be a single day. However, Council members were asked to hold two days to ensure flexibility should a situation arise where a longer meeting is required.

IV. ANNOUNCEMENTS

Dr. Stanfield

Confidentiality

Council members were reminded that material furnished for review purposes and discussion during the closed portion of the meeting is considered confidential. The content of discussions taking place during the closed session may be disclosed only by the staff and only under appropriate circumstances. Any communication from investigators to Council members regarding actions on an application must be referred to the Institute. Any attempts by Council members to handle questions from applicants could create difficult or embarrassing situations for the members, the Institute, and/or the investigators.